Journal Article

Defining Responses to Therapy and Study Outcomes in Clinical Trials of Invasive Fungal Diseases: Mycoses Study Group and European Organization for Research and Treatment of Cancer Consensus Criteria

Brahm H. Segal, Raoul Herbrecht, David A. Stevens, Luis Ostrosky-Zeichner, Jack Sobel, Claudio Viscoli, Thomas J. Walsh, Johan Maertens, Thomas F. Patterson, John R. Perfect, Bertrand Dupont, John R. Wingard, Thierry Calandra, Carol A. Kauffman, John R. Graybill, Lindsey R. Baden, Peter G. Pappas, John E. Bennett, Dimitrios P. Kontoyiannis, Catherine Cordonnier, Maria Anna Viviani, Jacques Bille, Nikolaos G. Almyroudis, L. Joseph Wheat, Wolfgang Graninger, Eric J. Bow, Steven M. Holland, Bart-Jan Kullberg, William E. Dismukes and Ben E. De Pauw

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 47, issue 5, pages 674-683
Published in print September 2008 | ISSN: 1058-4838
Published online September 2008 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/590566
Defining Responses to Therapy and Study Outcomes in Clinical Trials of Invasive Fungal Diseases: Mycoses Study Group and European Organization for Research and Treatment of Cancer Consensus Criteria

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Invasive fungal diseases (IFDs) have become major causes of morbidity and mortality among highly immunocompromised patients. Authoritative consensus criteria to diagnose IFD have been useful in establishing eligibility criteria for antifungal trials. There is an important need for generation of consensus definitions of outcomes of IFD that will form a standard for evaluating treatment success and failure in clinical trials. Therefore, an expert international panel consisting of the Mycoses Study Group and the European Organization for Research and Treatment of Cancer was convened to propose guidelines for assessing treatment responses in clinical trials of IFDs and for defining study outcomes. Major fungal diseases that are discussed include invasive disease due to Candida species, Aspergillus species and other molds, Cryptococcus neoformans, Histoplasma capsulatum, and Coccidioides immitis. We also discuss potential pitfalls in assessing outcome, such as conflicting clinical, radiological, and/or mycological data and gaps in knowledge.

Journal Article.  5838 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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